• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-20
Device Problems Obstruction of Flow (2423); Infusion or Flow Problem (2964); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/30/2022
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products:product id 8780 , serial# (b)(4), implanted: (b)(6)2022, explanted: (b)(6) 2022, product type: catheter, ubd: 22-sep-2023, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was receiving prialt (25mcg/ml at 3. 611mcg) via an implantable pump for non-malignant pain. It was reported that the healthcare provider (hcp) tried to aspirate the catheter intraoperatively and was unable to aspirate cerebrospinal fluid (csf) from the catheter access port.   the catheter was revised and the pump segment was replaced with successful aspiration.   the issue was reported to be resolved at the time of this report.   the patients weight and medical history were asked but would not be made available.   the patient was reported alive with no injury.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSYNCHROMED II
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key14015812
MDR Text Key288618576
Report Number3004209178-2022-04276
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/11/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/01/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/05/2022 Patient Sequence Number: 1
-
-